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Colosafe

by Creative Biosciences (Guangzhou) Co., Ltd.

Ref KLM-300110；KLM-300190

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-KLM-300110;KLM-300190XX Basic UDI-DI D-KLM-300110;KLM-300190XXUDI-DIDate20 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Methylation Detection Kit for Human SDC2 Gene (Real Time PCR)
Model / Reference
KLM-300110；KLM-300190
Primary DI / UDI-DI
D-KLM-300110;KLM-300190XX
Basic UDI-DI
B-KLM-300110;KLM-300190XX
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000034058
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Creative Biosciences (Guangzhou) Co., Ltd.

Properties

  • Human Tissues
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No